Safety in pregnant women and nursing mothers has not been established in this drug. Other botulinum toxin injection has been shown to produce abortions and effects at daily doses of 0.125 U/kg/day and at 2 U/kg and higher in rabbits; whereas in rats and mice, no abortions or effects were observed when up to 4 U/kg of botulinum toxin were injected. Doses of 8 and 16 U/kg in rats and mice have been shown to be associated with reduced fetal body weight and/or delayed ossification of the hyoid bone, which may be reversible.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NEURONOX is administered to a nursing woman.
NEURONOX is contraindicated in pregnancy and lactation.